A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
NCT ID: NCT05755438
Last Updated: 2025-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
204 participants
INTERVENTIONAL
2023-03-10
2025-08-13
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vehicle Cream BID
Participants apply ruxolitinib matching vehicle cream topically to the affected areas as a thin film twice daily (BID) for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will apply ruxolitinib 1.5% cream topically during the open label extension (OLE) period for up to 40 weeks.
Vehicle Cream
Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle controlled period (DBVC).
Ruxolitinib 1.5% Cream
Participants apply ruxolitinib 1.5% cream topically to the affected areas as a thin film BID for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will apply ruxolitinib 1.5% cream the open label extension (OLE) period for up to 40 weeks.
Ruxolitinib Cream
Ruxolitinib cream 1.5% twice daily (BID) during the vehicle controlled (DBVC)and open label treatment period (OLE).
Interventions
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Ruxolitinib Cream
Ruxolitinib cream 1.5% twice daily (BID) during the vehicle controlled (DBVC)and open label treatment period (OLE).
Vehicle Cream
Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle controlled period (DBVC).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening and baseline having a treatment area \<20% BSA.
* IGA-CPG-S score of ≥ 2 at screening and baseline.
* Baseline PN-related WI-NRS score ≥ 7.
* Willingness to avoid pregnancy or fathering children.
Exclusion Criteria
* Total estimated BSA treatment area (excluding the scalp) \> 20%.
* Neuropathic and psychogenic pruritus
* Active atopic dermatitis lesions within 3 months of screening and baseline.
* Uncontrolled thyroid function
* Concurrent skin or other serious or unstable medical conditions which may interfere with the evaluation of PN such as immunocompromised status, acute/chronic infections, active malignancy, history of TB, history of DVT/VTE, etc Protocol defined abnormal laboratory results.
* Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching.
* Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baseline or Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (within 2 weeks before baseline
* Pregnant or lactating, or considering pregnancy.
* History of alcoholism or drug addiction within 1 year
* Known allergy or reaction to any of the components of the study drug.
* Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.
* Employees of the sponsor or investigator or otherwise dependents of them.
* The following participants are excluded in France:
1. Vulnerable populations according to article L.1121-6 of the French Public Health Code.
2. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
3. Individuals not affiliated with the social security system.
18 Years
99 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Haq Nawaz, md
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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Medical Dermatology Specialists Phoenix
Phoenix, Arizona, United States
Johnson Dermatology
Fort Smith, Arkansas, United States
First Oc Dermatology
Fountain Valley, California, United States
Dermatology Associates Pc
Rockville, Maryland, United States
Clarkston Medical Group
Clarkston, Michigan, United States
Revival Research Institute, Llc Troy
Troy, Michigan, United States
Medisearch Clinical Trials
Saint Joseph, Missouri, United States
Wake Forest University
Winston-Salem, North Carolina, United States
UC Health, Llc
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
International Clinical Research Tennessee Llc
Murfreesboro, Tennessee, United States
North Texas Center For Clinical Research Ntccr
Frisco, Texas, United States
Austin Institute For Clinical Research Aicr Pflugerville
Pflugerville, Texas, United States
Center For Clinical Studies
Webster, Texas, United States
Premier Clinical Research
Spokane, Washington, United States
Conexa Investigacion Clinica S.A.
Buenos Aires, , Argentina
Cedic Centro de Investigaciones Clinicas
Ciudad Autonoma Buenos Aires, , Argentina
Buenos Aires Skin
Ciudad Autonoma Buenos Aires, , Argentina
Psoriahue-Medicina Interdisciplinar
Ciudad Autonoma Buenos Aires, , Argentina
Centro de Investigaciones Medicas Mar Del Plata
Mar del Plata, , Argentina
Fundacion Scherbovsky
Mendoza, , Argentina
Instituto de Especialidades de La Salud Rosario
Rosario, , Argentina
Centro de Investigaciones Medicas Tucuman
San Miguel de Tucumán, , Argentina
Ulb Hospital Erasme
Brussels, , Belgium
Cliniques Universitaires Ucl Saint-Luc
Brussels, , Belgium
Az Sint-Lucas
Ghent, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Universitair Ziekenhuis (Uz) Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, , Belgium
Chu Ucl Namur de Saint Elisabeth
Namur, , Belgium
Beacon Dermatology
Calgary, Alberta, Canada
Simcomed Health Ltd
Barrie, Ontario, Canada
Dermeffects
London, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
Centre de Recherche Saint-Louis
Québec, Quebec, Canada
Centro Medico Skinmed
Las Condes, , Chile
Ciec - Centro Internacional de Estudios Cli-Nicos
Santiago, , Chile
Clinical Research Chile Spa.
Valdivia, , Chile
Hospital Prive D'Antony
Antony, , France
Hospital Morvan
Brest, , France
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes, , France
University Hospital of Saint Etienne
Saint-Etienne, , France
University Medical Center Rwth Aachen
Aachen, , Germany
Fachklinik Bad Bentheim Dermatologie
Bad Bentheim, , Germany
Universitaetsklinikum Carl Gustav Carus Tu Dresden
Dresden, , Germany
Universitatsklinikum Schleswig Holstein
Kiel, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, , Germany
Universitats-Hautklink Tubingen
Tübingen, , Germany
Hautarztpraxis Dr. Med. Matthias Hoffmann
Witten, , Germany
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia (Presidio Spedali Civili)
Brescia, , Italy
Azienda Ospedaliero Universitaria Policlinico G.Rodolico San Marco
Catania, , Italy
Asl 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore
Coppito, , Italy
Azienda Ospedaliera Universitaria Policlinico 'Federico Ii'
Napoli, , Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs
Roma, , Italy
Ospedali Riuniti Di Ancona
Torrette, , Italy
Amsterdam University Medical Centre
Amsterdam, , Netherlands
Bravis Ziekenhuis
Bergen op Zoom, , Netherlands
Pratia McM Krakow
Krakow, , Poland
ETG LODZ
Lodz, , Poland
Kliniczny Szpital Wojewodzki Nr 1
Rzeszów, , Poland
Clinical Research Group Sp. Z.O.O
Warsaw, , Poland
High-Med Przychodnia Specjalistycza
Warsaw, , Poland
Centralny Szpital Kliniczny Mswia
Warsaw, , Poland
Hospital General Unviersitario de Alicante
Alicante, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital de Manises
Manises, , Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, , Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2022-501621-20-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCB 18424-319
Identifier Type: -
Identifier Source: org_study_id